Details for New Drug Application (NDA): 073588
NDA 073588 describes TOLMETIN SODIUM, which is a drug marketed by Ani Pharms, Chartwell Rx, Pharmazone, Rising, Sun Pharm Industries, and Cosette Pharms Nc, and is included in fourteen NDAs. It is available from five suppliers. Additional details are available on the TOLMETIN SODIUM profile page.
The generic ingredient in TOLMETIN SODIUM is tolmetin sodium. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the tolmetin sodium profile page.
The generic ingredient in TOLMETIN SODIUM is tolmetin sodium. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the tolmetin sodium profile page.
Summary for 073588
| Tradename: | TOLMETIN SODIUM |
| Applicant: | Chartwell Rx |
| Ingredient: | tolmetin sodium |
| Patents: | 0 |
Pharmacology for NDA: 073588
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 073588
Suppliers and Packaging for NDA: 073588
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TOLMETIN SODIUM | tolmetin sodium | TABLET;ORAL | 073588 | ANDA | Chartwell RX, LLC | 62135-062 | 62135-062-30 | 30 TABLET in 1 BOTTLE (62135-062-30) |
| TOLMETIN SODIUM | tolmetin sodium | TABLET;ORAL | 073588 | ANDA | Lifsa Drugs LLC | 72336-118 | 72336-118-30 | 30 TABLET in 1 BOTTLE (72336-118-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 200MG BASE | ||||
| Approval Date: | Jul 31, 1992 | TE: | RLD: | No | |||||
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